Data Management

With early phase clinical trials, we need to enter data in real time, which means the quality of data must be checked as it is being entered. Edit checks must be approached by defining unique metadata for each item such as time tolerances for procedures, soft and hard parameter ranges for numerical fields and calculations occurring in real time as data is entered. The ability to create custom validation checks, such as ensuring one date is after another date is also supported. To round off the data management features, queries can be routed, data reviewed and the study-locked-data exported in recognizable formats such as SAS Transport files.

Overview

Seoul University Hospital uses TrialOne as its standardized eSource system.